CorVista® System

K232686

CorVista Health, Inc. · cleared 2023-09-08 · product code QXX · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm. Machine learning-based algorithm”
Algorithmmachine learning-based algorithm
source quote (p.8)
“Machine learning-based algorithm”
Adaptive (vs locked)No
source quote (p.5)
“The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (6)

Bench

sample size not stated

endpoints: demonstrate the software operates and performs according to written and pre-approved specifications

Bench

sample size not stated

endpoints: battery lifecycle; signal quality; wireless coexistence; label integrity; other functional verification

Bench

sample size not stated

endpoints: meet acceptable performance to the following standards

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 80601-2-61, IEC 60259, IEC 62133, EC53:2013, AIM 7351731, ANSI IEEE C63.27, FCC 47CFR Part 15 Subpart C

Bench

sample size not stated

endpoints: Cytotoxicity; Maximization Testing for Delayed-Type Hypersensitivity; Intracutaneous (Intradermal) Reactivity Testing

standards: ISO 10993-1, ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010

Retrospective clinical

n=1,816 patients

endpoints: indicate the likelihood of significant coronary artery disease (CAD)

Retrospective clinical

sample size not stated

endpoints: repeatability and reproducibility of the CAD Add-On output (i.e., CAD Score)

Reported performance (3 observations)

sensitivity0.88
source quote (p.15)
“population was demonstrated to be 88% sensitivity and 51% specificity, with a 0.80 AUC-ROC.”
specificity0.51
source quote (p.15)
“population was demonstrated to be 88% sensitivity and 51% specificity, with a 0.80 AUC-ROC.”
aurocas written: “auc”0.8
source quote (p.15)
“population was demonstrated to be 88% sensitivity and 51% specificity, with a 0.80 AUC-ROC.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232686